A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.

NCT07357675 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: EasyBoost
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 5

Brief Summary

EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, participants who received EA-230 during Coronary Artery Bypass surgery stayed in the Intensive Care Unit (ICU) and the hospital for a shorter time and had fewer serious complications, compared to those who received a placebo (an inactive therapy). The use of EA-230 was safe and well tolerated. This trial will test EA-230 in more participants to see if it really works and is safe to use in the future. This is a Phase III trial. It will take place in multiple locations and will follow a double-blind, randomized, placebo-controlled clinical design, meaning neither doctors nor participants will know whether they receive EA-230 or placebo during the trial. Assignment to EA-230 or placebo occurs by chance, like throwing dice. The total duration of the trial, including medical check-ups, will be approximately 71 days. There is a total of 10 visits, including a screening-, a pre-operative-, and 2 remote visits. 7 of these visits are during your stay at the hospital.

Conditions

Coronary Artery Disease (CAD); Coronary Artery Bypass Graft Surgery(CABG)

Outcome Measures

Primary Outcomes (1)

• Required postoperative hospital length of stay

  Median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital.

  Up to 28 days

Secondary Outcomes (10)

• Required postoperative ICU length of stay

  Up to 28 days

• Actual postoperative hospital length of stay

  Up to 28 days

• Actual postoperative ICU length of stay

  Up to 28 days

• Single Organ Outcome Measures (SOOMs)

  Up to 28 days

• Net Fluid Balance (NFB) in milliliters (mL)

  Up to 2 days (48 hours) after start of surgery (first incision)

Study Arms (2)

EA-230 90mg/kg/hour

EXPERIMENTAL

Drug: EA-230 90mg/kg/hour

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EA-230 90mg/kg/hour DRUG

Intravenous administration of 90mg/kg per hour for 4 hours.

EA-230 90mg/kg/hour

Placebo DRUG

Placebo administered intravenously for 4 hours

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years, both male and female.
• Patients scheduled for elective on-pump CABG with at least 3 bypasses, with or without valve replacement.
• For women of childbearing potential (WOCBP), agree to use adequate contraception17 from enrollment and up to 28 days after IMP administration, and must have a negative pregnancy test prior to entry into the trial.
• For male patients, agree to use adequate contraception and refrain from donating sperm from enrollment and up to 28 days after IMP administration.
• Willing and able to give written informed consent.

You may not qualify if:

• Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.
• Cardiogenic shock or hemodynamic instability that requires inotropes, vasopressors, or other mechanical devices, such as an intra-aortic balloon counter-pulsation (IABP), within 24 hours prior to surgery.
• Use of a left ventricular assist device (LVAD), or intra-aortic balloon pump or other cardiac devices, within 7 days prior to surgery.
• A requirement for any of the following within 7 days prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, or other forms of mechanical circulatory support.
• Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery.
• Known chronic liver disorder with Child-Pugh C classification.
• Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery.
• Ongoing sepsis (as defined by SEPSIS-3) within 2 weeks of screening or, in the opinion of the investigator, an untreated clinically significant infection (viral or bacterial) prior to or at Screening and before randomization.
• Immuno-compromised patients, as self-reported or as observed in medical records, including patients:
• with solid organ transplantation.
• known to be positive for human immunodeficiency virus (HIV).
• that use immunosuppressive drugs or have received recent chemotherapy, at the discretion of the Investigator and including patients;
• i. with active malignancy who have undergone chemotherapy within 30 days prior to trial entry.
• Patients with hematological disorders (known disorders from myeloid and/or lymphoid origin, leucopenia (both active and in remission)).
• Known severe renal disease requiring dialysis, or a known estimated Glomerular Filtration Rate (eGFR) prior to admission of \< 20 ml/min/1.73 m2.

Sponsors & Collaborators

• EBI Anti Sepsis BV: lead
• CR2O B.V.: collaborator

Study Sites (5)

MAYO clinic

Rochester, Minnesota, 55905, United States

Location

UZ Gent

Ghent, Belgium

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

RadboudUMC

Nijmegen, Netherlands

Location

St Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

alanyl-glutaminyl-glycyl-valine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Peter Pickers, Prof.

  Radboudmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bas Ossenkoppele, Msc

CONTACT

+31 620033017; bas.ossenkoppele@cr2o.nl

Leonie Koomen, Msc

CONTACT

+31610518323; leonie.koomen@cr2o.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Phase III Trial

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (2); US (1); GB (1)